Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

Chronic Hepatitis b Clinical Trial

Official title:

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04676893
• Other study ID #: A99_02BE2002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 26, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: December 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Ji-Young Park, Professor
• Phone: +82-2-920-6288
• Email: jypark21[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Description:

To healthy subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: May 18, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy male volunteers, aged between = 19 and = 45 years old at the time of screening.

2. Weight = 50kg, with calculated body mass index (BMI) of = 18.5 and = 29.9 kg/m2

• BMI = Weight(kg)/ Height(m)2

3. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration

4. Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail

Exclusion Criteria:

1. History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.

2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.

3. Any medical history that may affect drug absorption, distribution, metabolism and excretion.

4. Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse

• Thiazolidinedione
• DPP-4 inhibitor
• Metformin

5. Any clinically significant chronic medical illness.

6. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

7. Individuals with one of the following laboratory test results in screening

• AST, ALT > UNL (upper normal limit) x 3
• Creatinine clearance = 80 mL/min
• In ECG result, QTc > 450 msec
• hCG(+) (only women)

8. Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.

9. Use of any prescription drugs within 14 days prior to study drug administration.

10. Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.

11. History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).

12. Individuals who cannot eat standard meal provided from clinical trial center.

13. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.

14. Individuals who had received a blood transfusion within 30 days prior to study drug administration.

15. Exposure to any investigational drug within 6 months prior to the first IP administration.

16. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.

17. Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.

18. Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking.

19. Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.

20. Pregnant or women who may be pregnant

21. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• D418 Tab.
1T
• CKD-388 Tab.
1T

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of CKD-388, D418	Area under the CKD-388/D418 concentration in blood-time curve from zero to final	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Primary	Cmax of CKD-388, D418	The maximum CKD-388/D418 concentration in blood sampling time t	Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours